Multiple Sclerosis Clinical Trial

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Summary

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent

Exclusion Criteria:

Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined

Exclusion criteria

known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

2060

Study ID:

NCT03650114

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 296 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35233, United States
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Cullman Alabama, 35058, United States
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Phoenix Arizona, 85013, United States
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Fullerton California, 92835, United States
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Sacramento California, 95817, United States
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Aurora Colorado, 80045, United States
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Basalt Colorado, 81621, United States
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Boulder Colorado, 80301, United States
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Colorado Springs Colorado, 80907, United States
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Denver Colorado, 80210, United States
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Fort Collins Colorado, 80528, United States
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Fort Collins Colorado, 80528, United States
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Newark Delaware, 19713, United States
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Washington District of Columbia, 20007, United States
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Atlantis Florida, 33462, United States
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Bradenton Florida, 34205, United States
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Delray Beach Florida, 33445, United States
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Maitland Florida, 32751, United States
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Miami Florida, 33032, United States
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Miami Florida, 33136, United States
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Naples Florida, 34102, United States
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Oldsmar Florida, 34677, United States
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Ormond Beach Florida, 32174, United States
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Pensacola Florida, 32514, United States
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Port Charlotte Florida, 33952, United States
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Sarasota Florida, 34233, United States
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Sarasota Florida, 34243, United States
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Sunrise Florida, 33351, United States
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Tallahassee Florida, 32312, United States
Novartis Investigative Site
Tampa Florida, 33603, United States
Novartis Investigative Site
Tampa Florida, 33609, United States
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Tampa Florida, 33612, United States
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West Palm Beach Florida, 33407, United States
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Savannah Georgia, 31406, United States
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Suwanee Georgia, 30024, United States
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Honolulu Hawaii, 96817, United States
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Chicago Illinois, 60612, United States
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Northbrook Illinois, 60062, United States
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Indianapolis Indiana, 46256, United States
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Des Moines Iowa, 50314, United States
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Kansas City Kansas, 66160, United States
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Overland Park Kansas, 66210, United States
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Alexandria Louisiana, 71301, United States
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Baton Rouge Louisiana, 70810, United States
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Wellesley Massachusetts, 02481, United States
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Detroit Michigan, 48201, United States
Novartis Investigative Site
Detroit Michigan, 48202, United States
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Plymouth Minnesota, 55446, United States
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Chesterfield Missouri, 63017, United States
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Ozark Missouri, 65721, United States
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Saint Louis Missouri, 63110, United States
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Billings Montana, 59101, United States
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Great Falls Montana, 59405, United States
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Las Vegas Nevada, 89106, United States
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Albuquerque New Mexico, 87131, United States
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Latham New York, 12110, United States
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Asheville North Carolina, 28806, United States
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Charlotte North Carolina, 28204, United States
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Greensboro North Carolina, 27405, United States
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Raleigh North Carolina, 27607, United States
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Winston-Salem North Carolina, 27103, United States
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Akron Ohio, 44320, United States
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Cleveland Ohio, 44195, United States
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Columbus Ohio, 43214, United States
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Westerville Ohio, 43082, United States
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Oklahoma City Oklahoma, 73104, United States
Novartis Investigative Site
Portland Oregon, 97225, United States
Novartis Investigative Site
Philadelphia Pennsylvania, 19107, United States
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Willow Grove Pennsylvania, 19090, United States
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Greer South Carolina, 29650, United States
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Spartanburg South Carolina, 29303, United States
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Spartanburg South Carolina, 29303, United States
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Cordova Tennessee, 38018, United States
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Johnson Tennessee, 37604, United States
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Knoxville Tennessee, 37920, United States
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Knoxville Tennessee, 37922, United States
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El Paso Texas, 79935, United States
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Houston Texas, 77074, United States
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Lubbock Texas, 79410, United States
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Round Rock Texas, 78681, United States
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San Antonio Texas, 78258, United States
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Sherman Texas, 75092, United States
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Salt Lake City Utah, 84103, United States
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Salt Lake City Utah, 84132, United States
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Virginia Beach Virginia, 23456, United States
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Kirkland Washington, 98034, United States
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Tacoma Washington, 98405, United States
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Green Bay Wisconsin, 54311, United States
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Madison Wisconsin, 53792, United States
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Milwaukee Wisconsin, 53215, United States
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Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
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Buenos Aires , C1424, Argentina
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Cordoba , X5004, Argentina
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Tucuman , 4000, Argentina
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Liverpool New South Wales, 2170, Australia
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New Lambton Heights New South Wales, 2305, Australia
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St Leonards New South Wales, 2065, Australia
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Vienna , 1090, Austria
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Wien , 1010, Austria
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Edegem Antwerpen, 2650, Belgium
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Brasschaat , 2930, Belgium
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Brugge , 8000, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Pleven , 5800, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1309, Bulgaria
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Sofia , 1413, Bulgaria
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Sofia , 1431, Bulgaria
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London Ontario, N6A 5, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Gatineau Quebec, J9J 0, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Montreal Quebec, H3A 2, Canada
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Quebec , G1J 1, Canada
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Rijeka HRV, 51000, Croatia
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Osijek , 31000, Croatia
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Zagreb , 10000, Croatia
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Brno Czech Republic, 656 9, Czechia
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Havirov Czech Republic, 736 0, Czechia
Novartis Investigative Site
Teplice Czech Republic, 415 0, Czechia
Novartis Investigative Site
Hradec Kralove CZE, 500 0, Czechia
Novartis Investigative Site
Olomouc CZE, 779 0, Czechia
Novartis Investigative Site
JIhlava , 586 0, Czechia
Novartis Investigative Site
Ostrava Poruba , 708 5, Czechia
Novartis Investigative Site
Pardubice , 532 0, Czechia
Novartis Investigative Site
Praha 10 , 100 3, Czechia
Novartis Investigative Site
Praha 4 , 140 5, Czechia
Novartis Investigative Site
Praha 5 , 150 0, Czechia
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Copenhagen , DK-21, Denmark
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Odense C , 5000, Denmark
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Tallinn , 10617, Estonia
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Tartu , 51014, Estonia
Novartis Investigative Site
Tampere , 33100, Finland
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Turku , 20520, Finland
Novartis Investigative Site
Nice Cedex1, 06001, France
Novartis Investigative Site
Lille Cedex , 59037, France
Novartis Investigative Site
Montpellier , 34295, France
Novartis Investigative Site
Nantes Cedex 1 , 44093, France
Novartis Investigative Site
Nimes , 30029, France
Novartis Investigative Site
Paris 13 , 75651, France
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Strasbourg , 67000, France
Novartis Investigative Site
Barsinghausen , 30890, Germany
Novartis Investigative Site
Bayreuth , 95445, Germany
Novartis Investigative Site
Bielefeld , D 336, Germany
Novartis Investigative Site
Bochum , 44791, Germany
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Dresden , 01307, Germany
Novartis Investigative Site
Essen , 45147, Germany
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Hamburg , 22179, Germany
Novartis Investigative Site
Hannover , 30625, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Koln , 50935, Germany
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Leipzig , 04103, Germany
Novartis Investigative Site
Marburg , 35043, Germany
Novartis Investigative Site
Minden , 32429, Germany
Novartis Investigative Site
Muenchen , 80377, Germany
Novartis Investigative Site
Muenchen , 81377, Germany
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Neuburg an der Donau , 86633, Germany
Novartis Investigative Site
Potsdam , 14471, Germany
Novartis Investigative Site
Siegen , 57076, Germany
Novartis Investigative Site
Ulm , 89073, Germany
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Unterhaching , 82008, Germany
Novartis Investigative Site
Athens GR, 115 2, Greece
Novartis Investigative Site
Thessaloniki , GR 54, Greece
Novartis Investigative Site
Budapest HUN, 1135, Hungary
Novartis Investigative Site
Budapest HUN, 1138, Hungary
Novartis Investigative Site
Budapest HUN, 1204, Hungary
Novartis Investigative Site
Budapest , 1106, Hungary
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Kistarcsa , 2143, Hungary
Novartis Investigative Site
Pecs , 7623, Hungary
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Szeged , 6725, Hungary
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New Delhi Delhi, 110 0, India
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New Delhi Delhi, 11001, India
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Kochi Kerala, 682 0, India
Novartis Investigative Site
Mumbai Maharashtra, 40000, India
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Pune Maharashtra, 41100, India
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Chandigarh Punjab, 16001, India
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Hyderabad Telangana, 50008, India
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Howrah West Bengal, 71110, India
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Mangalore , 57501, India
Novartis Investigative Site
Ashkelon , 78278, Israel
Novartis Investigative Site
Haifa , 31096, Israel
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Sefad , 13100, Israel
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Tel Aviv , 64239, Israel
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Toon-city Ehime, 791-0, Japan
Novartis Investigative Site
Sapporo city Hokkaido, 063-0, Japan
Novartis Investigative Site
Morioka Iwate, 020-8, Japan
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Sendai city Miyagi, 980 8, Japan
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Sendai city Miyagi, 983 8, Japan
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Kawagoe Saitama, 350 8, Japan
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Kodaira Tokyo, 187-8, Japan
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Shinjuku-ku Tokyo, 160 8, Japan
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Chiba , 260 8, Japan
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Niigata , 951 8, Japan
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Osaka , 556-0, Japan
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Riga LV, LV-10, Latvia
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Riga , LV 10, Latvia
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Riga , LV-10, Latvia
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Kaunas LTU, LT 50, Lithuania
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Vilnius , LT-08, Lithuania
Novartis Investigative Site
Ciudad de Mexico Distrito Federal, 06700, Mexico
Novartis Investigative Site
Mexico Distrito Federal, 03100, Mexico
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Morelia Michoacan, 58260, Mexico
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Chihuahua , 31238, Mexico
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Amsterdam , 1081 , Netherlands
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Rotterdam , 3015 , Netherlands
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Sittard-Geleen , 6162 , Netherlands
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Drammen , 1086, Norway
Novartis Investigative Site
Cercado De Lima Lima, 01, Peru
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San Isidro Lima, 27, Peru
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Lima , LIMA , Peru
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Bydgoszcz Woj Kujawsko-pomorskie, 85-79, Poland
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Gdansk , 80 95, Poland
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Gdansk , 80-46, Poland
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Gdansk , 80-80, Poland
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Glogow , 36-06, Poland
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Katowice , 40 57, Poland
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Kielce , 25 72, Poland
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Lodz , 90 32, Poland
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Rzeszow , 35 05, Poland
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Warszawa , 02 95, Poland
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Wroclaw , 51-68, Poland
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Zabrze , 41-80, Poland
Novartis Investigative Site
Matosinhos Porto, 44545, Portugal
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Braga , 47102, Portugal
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Coimbra , 3000 , Portugal
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Lisboa , 1169-, Portugal
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Lisboa , 1500 , Portugal
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Loures , 26745, Portugal
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Porto , 4099-, Portugal
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Santa Maria da Feira , 4520 , Portugal
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Ekaterinburg , 62010, Russian Federation
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Kazan , 42004, Russian Federation
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Kemerovo , 65006, Russian Federation
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Krasnoyarsk , 66004, Russian Federation
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Moscow , 12536, Russian Federation
Novartis Investigative Site
Moscow , 12701, Russian Federation
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Nizhny Novgorod , 60313, Russian Federation
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Nizhny Novgorod , 60315, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Novosibirsk , 63008, Russian Federation
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Saint Petersburg , 19404, Russian Federation
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Saint Petersburg , 19702, Russian Federation
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Saransk , 43003, Russian Federation
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Sestroretsk , 19770, Russian Federation
Novartis Investigative Site
St Petersburg , 19000, Russian Federation
Novartis Investigative Site
St. Petersburg , 19737, Russian Federation
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Tyumen , 62500, Russian Federation
Novartis Investigative Site
Banska Bystrica , 975 1, Slovakia
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Bratislava , 813 6, Slovakia
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Bratislava , 82606, Slovakia
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Bratislava , 83305, Slovakia
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Martin , 036 5, Slovakia
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Nitra , 94901, Slovakia
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Trnava , 917 7, Slovakia
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Pretoria , 0041, South Africa
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Rosebank , 2196, South Africa
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Cadiz Andalucia, 11009, Spain
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41009, Spain
Novartis Investigative Site
Hospitalet de Llobregat Barcelona, 08907, Spain
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Barcelona Cataluna, 08026, Spain
Novartis Investigative Site
Salt Cataluna, 17190, Spain
Novartis Investigative Site
Barcelona Catalunya, 08003, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Pozuelo de Alarcon Madrid, 28223, Spain
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El Palmar Murcia, 30120, Spain
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San Sebastian Pais Vasco, 20080, Spain
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Castilleja De La Cuesta Sevilla, 41950, Spain
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Baracaldo Vizcaya, 48903, Spain
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Madrid , 28006, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28222, Spain
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Valencia , 46026, Spain
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Goeteborg , 413 4, Sweden
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Stockholm , 102 3, Sweden
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Basel , 4031, Switzerland
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Lugano , 6900, Switzerland
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Tainan , 70403, Taiwan
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Khon Kaen THA, 40002, Thailand
Novartis Investigative Site
Sancaktepe Istanbul, 34785, Turkey
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Istanbul TUR, 34098, Turkey
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Haseki Istanbul , 34096, Turkey
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Istanbul , 34147, Turkey
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Izmir , 35040, Turkey
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Izmir , 35340, Turkey
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Kocaeli , 41380, Turkey
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Mersin , 33079, Turkey
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Samsun , 55139, Turkey
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Trabzon , 61080, Turkey
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Luton Beds, LU4 0, United Kingdom
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Headington Oxfordshire, OX3 9, United Kingdom
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Sheffield South Yorkshire, S10 2, United Kingdom
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Glasgow , G51 4, United Kingdom
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London , E1 1B, United Kingdom
Novartis Investigative Site
London , SW17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

2060

Study ID:

NCT03650114

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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